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| Name | Class |
|---|---|
| HK inno.N Corporation | INDUSTRY |
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The objective of this study is to examine the efficacy and side effect of varying dose of pregabalin for the treatment of postoperative pain after spinal surgery.
Patients experience considerable postoperative pain after spine surgery. Because the spine is located at the center of the body and supports body weight, severe postoperative pain hinders upper body elevation and gait which can lead to various complications such as pulmonary deterioration or pressure sores. It is important to effectively control postoperative pain to prevent such complications. Gabanoids are widely used as preemptive multimodal analgesia while their effects and side effects are known to be dose dependent. The objective of this study is to examine the efficacy and side effect of varying dose of pregabalin for the treatment of postoperative pain after spinal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 3 capsules of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours |
|
| Pregabalin 25mg | Experimental | 1 capsule of Kabalin 25mg Cap and 2 pills of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours |
|
| Pregabalin 50mg | Experimental | 2 capsules of Kabalin 25mg Cap and 1 pill of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours |
|
| Pregabalin 75mg | Experimental | 3 capsules of Kabalin 25mg Cap are administered once prior to surgery and every 12 hours after surgery for 72 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin 25 MG | Drug | Patients are given 0 to 3 capsules per administration according to their allocated group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Change of Visual analogue scale (VAS) pain score | Arrival at the general ward |
| Pain intensity | Change of Visual analogue scale (VAS) pain score | 6hours after surgery |
| Pain intensity | Change of Visual analogue scale (VAS) pain score | 24hours after surgery |
| Pain intensity | Change of Visual analogue scale (VAS) pain score | 48hours after surgery |
| Pain intensity | Change of Visual analogue scale (VAS) pain score | 72hours after surgery |
| IV PCA usage | amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA) | Arrival at the general ward |
| IV PCA usage | amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA) | 6hours after surgery |
| IV PCA usage | amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA) | 24hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea and vomiting due to IV PCA usage | Incidence and frequency of nausea and vomiting event due to IV PCA usage | From arrival at general ward after sugery for 72 hours, subdivided into 4 periods (1-6hours, 6-24hours, 24-48hours, 48-72hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Han-Dong Lee, Prof. | Contact | 82312195220 | ajouosspine@gmail.com | |
| Kihoon Park, Dr. | Contact | 82312197378 | kihoon05@aumc.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Han-Dong Lee, Prof. | Ajou University Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34424869 | Background | Helenius L, Yrjala T, Oksanen H, Pajulo O, Loyttyniemi E, Taittonen M, Helenius I. Pregabalin and Persistent Postoperative Pain Following Posterior Spinal Fusion in Children and Adolescents: A Randomized Clinical Trial. J Bone Joint Surg Am. 2021 Dec 1;103(23):2200-2206. doi: 10.2106/JBJS.21.00153. Epub 2021 Aug 23. | |
| 31770296 |
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| Placebo | Drug | Patients are given 0 to 3 capsules per administration according to their allocated group. |
|
| IV PCA usage |
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA) |
| 48hours after surgery |
| IV PCA usage | amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA) | 72hours after surgery |
| Rescue analgesic usage | Frequency of rescue analgesic administered | Arrival at the general ward |
| Rescue analgesic usage | Frequency of rescue analgesic administered | 6hours after surgery |
| Rescue analgesic usage | Frequency of rescue analgesic administered | 24hours after surgery |
| Rescue analgesic usage | Frequency of rescue analgesic administered | 48hours after surgery |
| Rescue analgesic usage | Frequency of rescue analgesic administered | 72hours after surgery |
| Helenius LL, Oksanen H, Lastikka M, Pajulo O, Loyttyniemi E, Manner T, Helenius IJ. Preemptive Pregabalin in Children and Adolescents Undergoing Posterior Instrumented Spinal Fusion: A Double-Blinded, Placebo-Controlled, Randomized Clinical Trial. J Bone Joint Surg Am. 2020 Feb 5;102(3):205-212. doi: 10.2106/JBJS.19.00650. |
| 21372654 | Background | Kim JC, Choi YS, Kim KN, Shim JK, Lee JY, Kwak YL. Effective dose of peri-operative oral pregabalin as an adjunct to multimodal analgesic regimen in lumbar spinal fusion surgery. Spine (Phila Pa 1976). 2011 Mar 15;36(6):428-33. doi: 10.1097/BRS.0b013e3181d26708. |
| Background | Panse NA, Adate KU, Panchal SH. Comparative Evaluation of Two Different Doses of Pre-Emptive Oral Pregabalin on Duration of Spinal Anesthesia and Postoperative Pain. Archives of Anesthesiology and Critical Care. 2021;7(2):75-81 |
| 37349841 | Derived | Park KH, Chung NS, Chung HW, Kim TY, Lee HD. Pregabalin as an effective treatment for acute postoperative pain following spinal surgery without major side effects: protocol for a prospective, randomized controlled, double-blinded trial. Trials. 2023 Jun 22;24(1):422. doi: 10.1186/s13063-023-07438-2. |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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